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NCT04523220 · ClinicalTrials.gov registry record · Phase 2
Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 704
- Enrollment target
NCT04523220 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 704 participants.
The verdict
NCT04523220, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 704 participants
- Enrollment target
Study Summary
In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels diseases. Osocimab is a human monoclonal antibody under development for the prevention of events caused by blood clots like heart attack, stroke and death due to heart or blood vessels diseases. It works by binding to and blocking the activated form of clotting factor XI which increases the formation and stability of clots. Researchers also want to find out how drug Osocimab works in human body and how the body absorbs, distributes and excretes the drug. Participants in this study will receive monthly injection of either Osocimab at a lower-dose or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.
Interventions
- DRUG Placebo
- DRUG BAY1213790 (Osocimab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 704 participants |
| Start Date | 2020-08-28 |
| Est. Completion | 2022-05-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04523220
The ClinicalTrials.gov registry entry for NCT04523220 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 704 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04523220 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04523220 about?
NCT04523220 is a clinical study titled "Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis". In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing...
What is the current status of trial NCT04523220?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 704 participants. The study started on 2020-08-28. Estimated completion is 2022-05-30.
What interventions are being tested in trial NCT04523220?
The interventions under investigation include: Placebo (DRUG), BAY1213790 (Osocimab) (DRUG).
Who is sponsoring clinical trial NCT04523220?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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